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Sponsor: Hospital Israelita Albert Einstein
Conditions: Cardiovascular Diseases, Atherosclerosis, Dyslipidemias
Interventions: Digitally-enabled Multifaceted Quality Improvement Intervention, Usual care
Countries: Brazil
Elevation in low density lipoprotein (LDL) cholesterol (LDL-C) is a causal risk factor for atherosclerotic established cardiovascular disease (ASCVD). Reduction of LDL-C with statins has been clearly demonstrated as a robust and cost-effective way of reducing the burden of ASCVD in individuals at risk. ASCVD is the leading cause of death and disability in Brazil and therefore prevention guidelines recommend LDL-C reduction with the aim of reducing disease burden in individuals at risk. Studies have shown a clear hiatus on awareness and treatment of cholesterol in Brazil. Thus, it became imperative to develop knowledge translation projects aiming at bridging the gap between science and clinical practice and ultimately leading to better outcomes. Cluster randomized clinical trials are the highest quality type of clinical research to test educational and active interventions aimed at changing behaviors or clinical practices. Therefore, this study is a pragmatic cluster randomized trial to assess the effect of a digitally enabled quality improvement intervention on LDL-C control in atherosclerotic established cardiovascular disease (ASCVD) patients.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Patient Eligibility Criteria:
Inclusion Criteria:
* Capable of using a smartphone with iOS or Android System AND
* Established ASCVD, including:
1. Coronary Artery Disease (CAD):
* Prior myocardial infarction
* Prior coronary revascularization - percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
* Angiographic or computerized tomography (CT)-imaging evidence of coronary atherosclerosis (≥ 50% stenosis in at least one major epicardial coronary artery)
2. Stroke:
• Prior ischemic stroke thought not to be caused by an embolic cause (e.g., atrial fibrillation, valvular heart disease or mural thrombus)
3. Peripheral Artery Disease (PAD):
* Prior documentation of a resting ankle-brachial index ≤ 0.9
* History of prior percutaneous or surgical revascularization of an iliac, femoral, or popliteal artery
* Prior non-traumatic amputation of a lower extremity due to peripheral artery disease
* History of prior percutaneous or surgical carotid artery revascularization
* Carotid Stenosis \> 50% on prior angiography or ultrasound AND
* Provision of informed consent
Exclusion Criteria:
* Patients with a recent cardiovascular event, less than 3 months prior to study inclusion
* Patients with LDL-C ≤ 50 mg/dL
* Current participation in other clinical trials involving lipid lowering treatments
* Patients that do not consent to trial participation
Cluster Eligibility Criteria:
Inclusion Criteria:
* Outpatient Clinics from public or private hospitals OR, Private Practices, which assist patients with previous ASCVD on secondary prevention that provide a unit/institution authorization form for participation in the trial AND
* Minimum monthly volume of 20 ASCVD patients
Exclusion Criteria:
* Clusters that do not provide the unit/institution authorization form.- Salvador, Estado de Bahia, Brazil
- Poços de Caldas, Minas Gerais, Brazil
- Campina Grande do Sul, Paraná, Brazil
- Joinville, Santa Catarina, Brazil
- Aracaju, Sergipe, Brazil
- Bragança Paulista, São Paulo, Brazil
- Campinas, São Paulo, Brazil
- Marília, São Paulo, Brazil
- Matão, São Paulo, Brazil
- Belém, Brazil
- Botucatu, Brazil
- Curitiba, Brazil
- Fortaleza, Brazil
- Goiânia, Brazil
- Goiânia, Brazil
- Maceió, Brazil
- Natal, Brazil
- Osasco, Brazil
- Porto Alegre, Brazil
- Porto Alegre, Brazil
- Presidente Prudente, Brazil
- Rio Branco, Brazil
- Rio de Janeiro, Brazil
- São José, Brazil
- São Paulo, Brazil
- São Paulo, Brazil
- São Paulo, Brazil
- Vila Velha, Brazil